Recall Z-0974-2013 ยท LLZ System, Image Processing, Radiological
Intio Inc
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
| Date | Mar 20, 2013 (initiated Feb 26, 2013) |
| Status | Terminated |
| Reason | INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use. |
| Root cause | Labeling False and Misleading |
| Action | INTIO sent a Recall Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. INTIO has corrected this version of the SVM User's Manual. An INTIO Inc. employee will contact the customers to replace the current manual with the correct one. Consignees were notified by letter that an INTIO Inc. employee will contact you within the next 30 days to replace the current manual with the correct one. The new SVM User's Manual will be provided to you once INTIO Inc. has retrieved the incorrect version of the SVM User's Manual. Cust |
| Quantity | 7 |
| Distribution | Nationwide Distribution including MN, FL, PA, WI, NY, and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113541 | CLEARSTART SVM SYSTEM Intio, Inc., Dec 16, 2011 |